Brief Summary

This study is a 6-month double-blind randomized trial comparing intra-detrusor botulinum toxin A (Botox A®) and anticholinergic therapy in women without neurologic disease with urge incontinence. All subjects will receive active drug and all subjects will receive placebo (see below). Subjects will be followed up to an additional six months off study drug to determine duration of treatment effect.

Primary Aim:

The primary aim is to compare the change in urge incontinence episodes over 6 months between women receiving a single intra-detrusor injection of 100 unit of botulinum toxin A (Botox A®) plus daily oral placebo tablets versus women receiving a single intra-detrusor injection of saline plus daily anticholinergic therapy. The null hypothesis is that there is no difference in the change from baseline in average number of urge urinary incontinence episodes over 6 months between groups.

The secondary aims are:

1) To compare efficacy of both treatments arms in reducing urgency and urge incontinence (occurrence and bother).

2) To assess duration of effect (time with adequate control of urinary leakage) of each treatment arm (single injection of 100U botulinum toxin A or 6 months of anticholinergic therapy)

3) To compare the change from baseline in pelvic floor-specific, sexual and overall quality of life measures and treatment satisfaction between botulinum toxin A and anticholinergic medication

8) To describe clinical and urodynamic parameters (measured at baseline) that are associated with effectiveness and side effects including new onset voiding dysfunction and partial urinary retention in both treatment groups

9) To describe the proportion of subjects who have adequate symptom control with the active standardized anticholinergic regimen

Contact Information

3) Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type.

4) Urge predominant (urge >50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary.

5) Demonstrated ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization in the event that this would be required.

1) Any previous therapy with trospium chloride, solifenacin, or darifenacin

2) Failed three or more anticholinergic drugs.

Note: We define drugs based on the active compound of the particular medication. Any and all formulations of a particular active compound will be considered as a single drug trial. Specifically, any and all formulations of oxybutynin will be considered a single attempt with this active compound. Any use of tolterodine or fesoterodine will be considered a single drug trial of fesoterodine.

3) Contraindication to anticholinergic therapy, specifically with solifenacin or trospium.

4) Current symptomatic urinary tract infection that has not resolved prior to randomization.

16) Currently pregnant or lactating patients or patients planning pregnancy within the next year.

17) Sexually active premenopausal women with a uterus who have either not had a tubal ligation or are not on a medically approved form of contraception for at least 3 months prior to and throughout the duration of the study.

18) Cystoscopic findings that preclude injection, in the opinion of the investigator.

19) Current or prior bladder malignancy.

20) In the opinion of the investigator, inability to understand diary instructions and complete 3-day voiding diary.